RecruitingPhase 2NCT07065240

A Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 Study)

A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Monotherapy Study of the Efficacy, Safety, and Tolerability of SPT-300 in Adults With Major Depressive Disorder (MDD), With or Without Anxious Distress

Sponsor

Seaport Therapeutics

Enrollment

360 participants

Start Date

Jun 19, 2025

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder (MDD)Major Depressive Disorder With Anxious Distress

Summary

This is a randomized, parallel-group, double-blind, placebo-controlled, monotherapy study to evaluate the efficacy, safety, and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study (BUOY-1) tests a new treatment called SPT-300 (also known as GlyphAllo) for adults with major depressive disorder (MDD) — a serious form of depression — to evaluate whether it safely reduces depressive symptoms over the course of the trial. **You may be eligible if...** - You are between 18 and 65 years old - You have a primary diagnosis of major depressive disorder - You are currently experiencing a depressive episode that has lasted at least 4 weeks but no longer than 18 months - You may also have generalized anxiety, social anxiety, or panic disorder — as long as depression is your primary diagnosis **You may NOT be eligible if...** - You do not have a confirmed diagnosis of major depressive disorder as your primary condition - Your depressive episode has lasted longer than 18 months - You are pregnant or planning to become pregnant during the study - You have other medical or psychiatric conditions that the study excludes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSPT-300

A prodrug of allopregnanolone, a small molecule drug

DRUGPlacebo

Placebo for SPT-300

Locations(45)

Seaport Investigator Site

Chino, California, United States

Seaport Investigator Site

Garden Grove, California, United States

Seaport Investigator Site

Glendale, California, United States

Seaport Investigator Site

Cromwell, Connecticut, United States

Seaport Investigator Site

West Palm Beach, Florida, United States

Seaport Investigator Site

Atlanta, Georgia, United States

Seaport Investigator Site

Decatur, Georgia, United States

Seaport Investigator Site

Marietta, Georgia, United States

Seaport Investigator Site

Boston, Massachusetts, United States

Seaport Investigator Site

Boston, Massachusetts, United States

Seaport Investigator Site

St Louis, Missouri, United States

Seaport Investigator Site

Brooklyn, New York, United States

Seaport Investigator Site

New York, New York, United States

Seaport Investigator Site

Staten Island, New York, United States

Seaport Investigator Site

Independence, Ohio, United States

Seaport Investigator Site

North Canton, Ohio, United States

Seaport Investigator Site

Irving, Texas, United States

Seaport Investigator Site

Plovdiv, Bulgaria

Seaport Investigator Site

Sofia, Bulgaria

Seaport Investigator Site

Sofia, Bulgaria

Seaport Investigator Site

Brno, Czechia

Seaport Investigator Site

Pilsen, Czechia

Seaport Investigator Site

Prague, Czechia

Seaport Investigator Site

Prague, Czechia

Seaport Investigator Site

Prague, Czechia

Seaport Investigator Site

Prague, Czechia

Seaport Investigator Site

Berlin, Brandenburg, Germany

Seaport Investigator Site

Schwerin, Mecklenburg-Vorpommern, Germany

Seaport Investigator Site

Bad Homburg, Germany

Seaport Investigator Site

Chemnitz, Germany

Seaport Investigator Site

Bełchatów, Poland

Seaport Investigator Site

Bialystok, Poland

Seaport Investigator Site

Bialystok, Poland

Seaport Investigator Site

Bydgoszcz, Poland

Seaport Investigator Site

Gdansk, Poland

Seaport Investigator Site

Katowice, Poland

Seaport Investigator Site

Leszno, Poland

Seaport Investigator Site

Poznan, Poland

Seaport Investigator Site

Torun, Poland

Seaport Investigator Site

Tuszyn, Poland

Seaport Investigator Site

Warsaw, Poland

Seaport Investigator Site

Wroclaw, Poland

Seaport Investigator Site

Bratislava, Slovakia

Seaport Investigator Site

Rimavská Sobota, Slovakia

Seaport Investigator Site

Vranov nad Topľou, Slovakia

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NCT07065240

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